The following data is part of a premarket notification filed by Arthrotek, Inc. with the FDA for Resorbable Lactosorb-l Acl Crosspin.
| Device ID | K014305 |
| 510k Number | K014305 |
| Device Name: | RESORBABLE LACTOSORB-L ACL CROSSPIN |
| Classification | Pin, Fixation, Smooth |
| Applicant | ARTHROTEK, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Sara B Shultz |
| Correspondent | Sara B Shultz ARTHROTEK, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-31 |
| Decision Date | 2002-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304421349 | K014305 | 000 |
| 00880304421332 | K014305 | 000 |
| 00880304421325 | K014305 | 000 |
| 00880304421318 | K014305 | 000 |
| 00880304421301 | K014305 | 000 |
| 00880304421295 | K014305 | 000 |